Ascensia Diabetes Care: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ascensia Diabetes Care” (first 2016, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 221 days. Since 2017 the median was 190 days, against 223 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 252 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 179 |
| 2020 | 0 | — |
| 2021 | 2 | 450 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 259 |
| 2025 | 0 | — |
| 2026 | 1 | 190 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ascensia Diabetes Care took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 6 | 6 |
Review panels
Most recent Ascensia Diabetes Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | NBW | 2026-08-27 | 190 |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | NBW | 2024-02-23 | 259 |
| K193407 | Contour® next GEN Blood Glucose Monitoring System | NBW | 2021-12-23 | 745 |
| K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | NBW | 2021-08-11 | 156 |
| K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System | NBW | 2019-11-08 | 179 |
| K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | NBW | 2016-11-17 | 252 |
Recalls
openFDA lists no recalls under a recalling firm named Ascensia Diabetes Care.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ascensia Diabetes Care is the lead sponsor of 41 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06053593: Ketostix® and Keto-Diastix® Performance Study (Completed, started 2023-07-24)
- NCT05449795: Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults (Completed, started 2022-11-29)
- NCT05467345: Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples (Completed, started 2022-08-24)
- NCT05647824: User Performance of the TV4 BGMS (Completed, started 2020-02-05)
- NCT04033315: Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus (Completed, started 2019-07-15)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ascensia Diabetes Care U.S., Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ascensia Diabetes Care?
FDA lists 6 510(k) clearances under the applicant name “Ascensia Diabetes Care” (first 2016, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ascensia Diabetes Care?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ascensia Diabetes Care is 221 days. Since 2017: 190 days, versus 223 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ascensia Diabetes Care?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 6).
Next steps
- See all 6 Ascensia Diabetes Care clearances with predicates and recalls
- Run predicate analysis for product code NBW, Ascensia Diabetes Care's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.